Facility Engineer, MACS Senior Specialist (On-site)

1000 Merck Sharp & Dohme LLC; Rahway (NJ); Presencial; USD 117.000 - 184.000; Tempo integral

Resumo da vaga

Merck & Co., Inc. in Rahway, NJ is seeking a Sr. Specialist Facility Engineer to mentor technical teams and lead equipment start-up, qualification, and commissioning for the Modality Agnostic Chemistry Scaleup Center.

The role supports GMP clinical manufacturing readiness and collaboration across Enabling Facilities. Responsibilities include participating in capital projects, driving process improvements, and ensuring safety, quality, and reliability of facilities and utilities.

Qualificações

• Experience with Good Manufacturing Practice facility design and equipment start-up/qualification.
• Strong mechanical aptitude and ability to read P&IDs.
• Familiarity with electrical classifications and process safety analyses.
• Experience interacting with tradesmen and construction management organizations.
• Knowledge of GMP regulations and change management processes.

Responsabilidades

• Provide technical mentorship and support to the Modality Agnostic Chemistry Scaleup Center.
• Support capital project close-out, commissioning/qualification, and readiness activities.
• Collaborate with cross-functional teams to ensure quality and safe delivery of clinical supplies.

Conhecimentos

GMP facility design

Equipment start-up

P&ID reading

PHA/LOPA

Change Management

Equipment Qualification

Facility Operations

Mentorship

Communication

Problem Solving

Formação

B.S. in Engineering

M.S. in Engineering

Ph.D. in Engineering

Ferramentas

Hexagon

SAP

Microsoft Office

Descrição da vaga

Job Description Description: The Enabling Facilities group within the Chemical Engineering Research & Development Department is seeking a highly motivated individual to work in a fast-paced job that provides a high degree of technical, mechanical, and project management responsibility. The Facility Engineer position will report to the Associate Director, Engineering and will be a member of the Equipment Development and Facility Engineering team. Enabling Facilities is responsible for development of new technologies/capabilities, execution of capital and non-capital improvement projects, and the automation system assets spanning production, utility systems and associated infrastructure. Equipment Development and Facility Engineering role within Enabling Facilities includes design, installation, qualification, startup, maintenance, troubleshooting and continuous improvement of equipment.

Responsibilities

This role at the Sr. Specialist level will serve as a technical mentor and process team member supporting the Modality Agnostic Chemistry Scaleup Center. This is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and Good Manufacturing Practice clinical manufacturing plant currently under construction. As the Modality Agnostic Chemistry Scaleup Center is nearing construction completion, the selected candidate will contribute to completing the capital project by supporting construction close-out, equipment and facility commissioning/qualification, as well as other critical operations readiness activity workstreams. The selected candidate is expected to foster a culture of collaboration, learning and innovation within Enabling Facilities, the Modality Agnostic Chemistry Scaleup Capital Project and Modality Agnostic Chemistry Scaleup Operations. After the facility starts up, they will collaborate closely with Enabling Facilities and Modality Agnostic Chemistry Scaleup Operations team members, development engineers & chemists, and compliance representatives, to ensure the quality and safe delivery of clinical supplies, the availability and reliability of facilities, the scientific rigor of the processes and ultimately enable flexibility and speed in the Company’s pipeline.

Additional Supported Areas

The Sr. Specialist may also support new and/or existing facilities across the Small Molecule Process Research & Development network and Enabling Facilities capital projects as required. Examples of these other areas are: Small Scale Organics Pilot Plant (SSO): The SSO is a Good Manufacturing Practice manufacturing facility in the Process Research and Development organization. The pilot plant’s mission is to serve as Process Research and Development internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing Good Manufacturing Practice steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites. Prep Lab Area: The Prep Lab is used to generate data which contributes to process definition and provides Phase I/IIa clinical material when needed. This kilo scale capability establishes reaction parameters and ensures successful batches when transferring to pilot scale. Areas of the Prep Lab have been and are continuing to be upgraded to support pipeline programs such as ADCs, PDCs, and other cross modality compounds that require a more flexible potent compound processing space.

Minimum Requirements

Required Education: Bachelor of Science degree in an Engineering or related scientific field with minimum of 6 years relevant experience, or Master’s degree with 5 years of relevant experience, or PhD degree with 2 years of relevant experience.

Required Experience and Skills: Experience with Good Manufacturing Practice facility design and equipment start-up and/or qualification. Strong mechanical aptitude. Ability to read and understand P&IDs. Familiarity with Electrical Classifications for solvent and dust (Class I and II, Div I and II). Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA) Experience interacting with skilled mechanical tradesmen and construction management organizations. Experience operating/maintaining manufacturing, pilot scale or prep lab scale equipment. Experience in supporting compliance investigations and change management. Familiarity with US and EU Good Manufacturing Practice and Safety compliance regulations Familiarity with Change Management processes and principles. Ability to comprehend and/or prepare Standard Operating Procedures and Good Manufacturing Practice documents. Fluent in Microsoft Office, use of email, and meeting facilitation. Effective interpersonal and communication skills, both verbal and written. Sound decision-making skills, knowing when to elevate vs. taking action, and ability to explain rationale for decisions. Excellent organizational skills to multi-task. Desire and willingness to learn, contribute and lead. Track-record of independent problem-solving.

Desired Experience and Skills

Experience in capital projects, specifically as the end-user Experience providing technical mentorship. Experience with Potent Compound processing and containment systems. Experience interacting with or overseeing the management of process utility system associated with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems, etc. Experience with coordinating maintenance activities around processing activities to support reliable facility operation. Experience with Process Analytical Technology. Experience with development of new instrumentation technologies. Trained in use of Hexagon for Plant Maintenance management and SAP for financial transactions. EligibleforERP Required Skills: Asset Management, Automation Systems, Equipment Qualification, Facility Design, Facility Engineering, Facility Operations, Good Manufacturing Practices (GMP), Hazard Analysis, Maintenance Strategy, Mentorship, Process Hazard Analysis (PHA), Process Optimization, Project Closeout, Root Cause Analysis (RCA), Technical Problem-Solving.

Preferred Skills

US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts

Location

The primary location for this posting is: USA - New Jersey - Rahway

Salary

The salary range for the primary location of this role is: $117,000.00 - $184,200.00. This range reflects the Company’s reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Additional location(s)

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location. Additional location(s) Compensation Information: San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives

Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status and Work Arrangements

Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a

Job Posting End Date

Job Posting End Date: 11/27/2026

About the Company

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.